In this work, we will develop ?RAPID COVIDX?, a rapid screening technology for COVID-19 based on simultaneous detection of SARS-CoV-2 antigen (Ag) and antibodies to SARS-CoV-2 virus (IgG/IgM) in human blood and/or nasal/throat swab specimens within 15 minutes at the point of care (POC). This will leverage the NIH-funded FeverPhone platform, which we have already shown capable of rapidly quantifying both antigens and antibodies at the POC for several infections, including malaria (pLDH and HRP2) and dengue/chikungunya virus infection (IgG/IgM). The RAPID COVIDx technology builds on our team's extensive background in the development of smartphone-based diagnostics, infectious disease, and global health. The technical effort of this program comprises of the development of in vitro immunochromatographic one-step assay to simultaneously detect SARS-CoV-2 specific IgG/IgM antibodies and antigens, a low-cost portable test strip reader for imaging the test strips, and a mobile app to provide step-by-step instructions to the user. By the end of this project, we will have developed a ?sample-in, answer-out? working prototype that will be ready for further validation with archived serum samples and for testing deployment readiness in POC settings. Serological tests such as the one proposed are going to be increasingly needed with the spread of the pandemic to both identify those with infection but also those with past exposure. Further, this will be critical to determine those who can return to work and those who are vulnerable and direct limited resources. Key assets of our platform include minimal needs for infrastructure, training, and sample volume. Additionally, the same platform works for multiple diseases/infections and can be commercialized at very low price points for both the reader and test strips. Last but not least, the PIs also have started a company commercializing similar technology for nutritional tests; there is capacity invested by the New York State and the Department of Defense at this startup to scale up manufacturing of these tests and are also familiar with the licensing process to engage other partners for rapid commercialization.
The COVID-19 outbreak is a global pandemic in progress, and early diagnosis and supportive treatment are critical for preventing mortality and decreasing morbidity associated with SARS-CoV-2 infection. One of the many challenges encountered by health care professionals has been screening for COVID-19 cases, mainly due to the lack of laboratory infrastructure to handle high number of specimens, limited availability of tests, and their relatively long time to provide results. We propose to develop and validate RAPID COVIDX, a point-of-care screening technology for COVID-19, based on simultaneous detection of SARS-CoV-2 antigen and antibodies to SARS-CoV-2 virus (IgG/IgM) in human samples, leveraging our NIH-funded FeverPhone diagnostic platform.
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